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Completed

NCT Number: NCT03427385

Minimum Local Anesthetic Dose for Adductor Canal Block

The purpose of this study is to determine the minimum dose of ropivacaine 0.5%, required to produce pain relief without weakening the leg muscles.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

About this study

The post-operative period after a Total Knee Arthroplasty (TKA) is known to be especially painful for the first 24 hours. Significant pain can persist up to 3 days in some cases. Successful management of pain post TKA is therefore regarded as essential to early recovery, rehabilitation and timely discharge.

Until now, multiple modes of analgesia have been employed including intravenous patient-controlled analgesia, continuous femoral nerve block and epidural analgesia. These are all effective alternatives but each is limited by side effects. Epidural analgesia provides excellent pain control and has been associated with early rehabilitation despite its negative impact on ambulation in the immediate peri-operative period. Additionally, an increased risk of spinal hematoma has been reported with epidural analgesia and peri-operative low molecular weight heparin prophylaxis. For this reason, epidural analgesia is not routinely offered to patients undergoing TKA today.

A multimodal analgesic approach centered on the use of continuous femoral nerve blocks has been more recently favoured, providing superior analgesia and less opioid-related side effects than a systemic opioid-based regimen. However, femoral nerve blockade is also associated with significant quadriceps muscle weakness, which can impair ambulation, delay physiotherapy and result in accidental fall.

Recent reports suggest that saphenous nerve blockade using an adductor canal approach is a novel technique with which to provide adequate analgesia for major knee surgery. Ultrasound-guided saphenous nerve block in the adductor canal is considered a technically simple and reliable block, providing consistent success. Although traditionally used to provide anesthesia and analgesia to the foot and ankle, recent reports suggest that saphenous nerve blockade in the adductor canal may provide adequate analgesia for major knee surgery. Taking into consideration the anatomy of the adductor canal, it appears possible to target not only the saphenous nerve but also multiple branches of the femoral and obturator nerve.

However, the optimal dose of local anesthetic required to establish knee analgesia without inducing quadriceps weakness has not yet been determined. Identifying an optimal dose would allow for maximum analgesic efficacy with minimal or no motor block, while minimizing other unwanted adverse effects.

This pilot study is designed to determine the optimal dose of ropivacaine 0.5% required to initiate sensory knee analgesia for the post-operative.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA(American Society of Anesthesiologists)physical status classification system I-III
  • 18-85 years of age, inclusive
  • BMI 18 - 40
  • Scheduled for elective total knee replacement under spinal anesthesia or general anesthesia.

Exclusion criteria

  • Inability or refusal to provide informed consent
  • Any contraindication to regional anesthesia (allergy to local anesthetics, bleeding diathesis, coagulopathy, malignancy or infection at the site of block)

Treatment and study plan

Ropivacaine 0.5%

Drug

The volume of local anesthetic Ropivacaine 0.5% will be determined by the response (success or failure of block, 30 minutes after local anesthetic injection) of the previous patient in that group. Block success is defined as an absence of ice sensation in the knee within 30 min of ropivacaine administration accompanied by tolerance to tetanic electrical stimulation (TES) at 60 mA(milliamp) for 5 seconds.

Other names: Naropin

Primary outcomes

  1. Tolerance to Transcutaneous Electrical Stimulation (TES)

    Time frame: 30 min after ropivacaine injection

    To determine the minimum effective dose of ropivacaine in the adductor canal block to initiate sensory analgesia in the knee. Complete sensory anesthesia in the knee following adductor canal block 30 minutes after ropivacaine administration.

Secondary outcomes

  1. The degree of motor block following ropivacaine administration

    Time frame: Assessments will start at baseline before ropivacaine injection and every 5 minutes after ropivacaine injection until 45 minutes have passed or until surgery commences, whichever comes first

    Motor block will be assessed using an isometric force dynamometer

  2. Cold sensation

    Time frame: 30 min after ropivacaine injection

    To determine the minimum effective dose of ropivacaine in the adductor canal block to initiate sensory analgesia in the knee. Complete sensory anesthesia in the knee following adductor canal block 30 minutes after ropivacaine administration.

Other outcomes

  1. Total opioid consumption

    Time frame: 48 hours

    Total opioid consumption during the intraoperative phase, post-operative care unit stay, and during the first 48 hours post-surgery

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Minimum Effective Local Anesthetic Dose for Adductor Canal Block for Knee Analgesia - a Preliminary Study

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 9, 2018
Registry last updated
Feb 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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